Many hospitals have started the ISO 9001 journey. This journey probably started because the hospital wanted a fresh and new approach with their accreditation. For the first time a hospital could begin to decide how they would meet requirements and not have to abide by a prescriptive way of doing things.
To implement the DNV-GL accreditation requires a hospital to establish a formal quality management system (QMS). This QMS is based on the framework of ISO 9001:2008 and now requires a transition to the 9001:2015 standard. But guess what, ISO only tells you WHAT you have to do and not HOW to do it. Now the problem begins, so let’s look at these 3 reasons to gain understanding.
Reason number 1: The original message on how to best learn and implement ISO 9001 was to send someone to an ISO 9001 Lead Auditor course. This course is intense and overwhelming for many of the attendees. I know because I have taken the course myself and my hand never really did recover from all that writing. In addition to being a student in one of those courses, I am a trainer for the week long course. Yes, that is right, I admit it. I am one of the few trainers for the 9001 Lead Auditor for Healthcare course in addition to the 9001 Internal Auditor course for healthcare. The lead auditor course really is a great course. It is accredited by Exemplar Global and at the end of the course; you get a certificate which is a personal certification to the lead auditor requirements. Great! But what does that mean exactly?
That means you have successfully completed a training course (Congratulations, you did earn it!) which is a requirement to be a lead auditor for a certification body – like DNV-GL. In addition to one of these lead auditor courses, you must perform a number of ISO 9001 audits (measured in days) where you were the lead auditor and some you may have just been a team member. Then you submit your audit log, certification number from your class, and of course a check (over $500 the first year) to one of the ISO auditing registrars like Exemplar Global and now you are an official card carrying lead auditor for an ISO 9001 QMS (I admit I am one of those nerds). Why would you do that? Because it is a requirement to be a lead auditor for a certifying organization like DNV-GL and other registrars. It really is a great course, BlueSynergy Associates offers it for a reason and we deliver the course in-house and publicly.
Question: Did you notice how I never mentioned how this course will help you plan, document, implement, and improve your 9001 QMS, especially how to transition to the new 2015 standard? – That’s right; I did not say any of those things. Here is a better option for those looking for more or better education, especially as it applies to helping a hospital move from being a reactive culture to being a proactive one – think “PRN”. Click the “better option” link above and see what I mean.
Reason number 2: Most of the common implementation methods that you have been exposed to came from the automotive & manufacturing industries. I don’t consider healthcare as an industry, we don’t have smoke stacks filling the sky and we certainly do not produce standardized “widgets”. Healthcare is a profession. It is a profession in which we provide complex services to people, our patients. When our processes fail we potentially harm a person; when manufacturing fails they make an inferior product. Big Difference!
Reason number 3: You hired a food critic to teach you how to become a chef! Wait, what? Let me explain. Hiring a consultant with a background primarily in surveying / auditing to provide input for your QMS is like hiring a food critic to teach you how to cook. Being a great food critic does not make you a chef. A food critic has many talents and has sampled a lot of food presumably, but knowing how to critique food does not necessarily translate to knowing how to teach someone how to cook.
I’ll explain further. Many ISO surveyors become consultants or moonlight as consultants. This brings some benefits as well as some shortcomings (see Reason # 2 above, guess where they got their start?). Think of a former ISO surveyor as the food critic. Their job as a surveyor is to look for compliance; are you meeting your requirements. Being compliance minded is the major drawback. Yes, they have seen many examples of how to meet a requirement (food critic), but most truly lack the experience of how (chef) to use ISO standards as a performance framework. If you use a chef to teach you how to cook and a food critic to tell you objectively what you are missing, you will have better outcomes. Each individual is working in an area they know best.
Now let’s put a bow on these problems. Each year, your leadership is expected to manage costs and improve the value of care you provide to your patients. The DNV-GL accreditation model was built with these same goals in mind. However, your QMS that is maturing, is not showing the ROI everyone had hoped and may not be maturing at the rate necessary to keep up with increasing demands on your hospitals’ needs. Your internal audit program and all of your internal auditors are supposed to add value through the internal audits and their findings. Yes, they do have findings, but no one is necessarily sure how or if the findings are seen as a value to leadership and that the resources applied to your QMS & accreditation are producing results which are truly recognized as an asset to your hospital.
Your transition to the 2015 standard is the perfect time to pivot your QMS and show your leadership that accreditation doesn’t have to cost, it should pay. After all, this is likely why many hospitals left TJC and moved to DNV-GL. The 2015 QMS standard requires integration of your patient care with your strategy and business processes. This alignment will help drive high reliability as well as high value patient care.
Some questions to ponder?
- Do you think that simply rebranding ISO 9001:2008 courses for ISO 9001:2015 will help you realize value?
- Do you think this same way of thinking will help you pivot your QMS to the original vision you had with DNV-GL?
Until next time,
Bio:
Eric Schulze is a Certified Enterprise Risk Manager (CERM©), and a Senior Advisor with BlueSynergy Associates, LLC. BlueSynergy Associates maximize innovation, experience and customer perspective to reduce risk and make hospitals a safer environment. He currently advises and instructs hospitals in quality, risk, safety and environmental management systems. Eric was a principal strategist and consultant in the largest ISO 9001 implementation at the Veterans Administration. He previously was involved in Risk Assurance in the pharmaceutical supply chain and is a certified Lead Auditor in quality management systems by Exemplar Global. He can be reached by email at eschulze@bluesynergyassociates.com
BlueSynergy Associates offers a FREE webinar. The webinar covers some of the changes from the 2008 standard to the 2015 standard, an intro to risk-based thinking, and some thoughts on transition planning. It is an hour in length and it is delivered entirely from the healthcare perspective. Check it out or forward it to a friend, or even better, check it out and forward to a friend.